IRA Effect: Alnylam Acting ‘Rationally’ In Halting Second Orphan Indication For Amvuttra – Analysts

Alnylam decision has been seized by opponents of Medicare price negotiation as evidence the nascent program will undermine innovation, particularly for small molecule drugs.

Price Controls In The Law Driving Shifts In Pipeline Plans • Source: Shutterstock

Rare disease treatment developer Alnylam Pharmaceuticals Inc. has scrapped plans to begin a Phase III study on use of its second-generation RNAi product Amvuttra (vutrisiran) in a second orphan drug indication because having more than one orphan indication could make the drug subject to Medicare price negotiation under the Inflation Reduction Act.

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UK Health Secretary Admits VPAG ‘More Expensive’ Than Expected & Needs To Be ‘Resolved’

 

The UK government has listened to industry concerns about high clawback rates under the voluntary scheme and will review it in June in a bid to resolve the issue and “move on to bigger and more important things,” health secretary Wes Streeting says.

Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
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Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?

Dr. Oz Takes Over CMS Amid Major Transformation Of Medicare Part D

 
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As CMS administrator, Mehmet Oz will oversee the second cycle of Medicare drug price negotiations and Part D redesign issues, but will have experienced deputies to help.

Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 

Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.

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Trump’s Tariffs Will Lead To ‘Instability’ And ‘Less Investment’ In UK

 

While the pharma industry appears to be exempt from US tariffs imposed by President Trump, a member of the UK House of Lords says the details are unknown and warned that uncertainty “leads to less investment” in business as a whole.

Industry Benefits As EU CTIS Hits Global Data Sharing Milestone

 

The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.

UK Health Secretary Admits VPAG ‘More Expensive’ Than Expected & Needs To Be ‘Resolved’

 

The UK government has listened to industry concerns about high clawback rates under the voluntary scheme and will review it in June in a bid to resolve the issue and “move on to bigger and more important things,” health secretary Wes Streeting says.